Version May 2024
Zaire ebolavirus infection (including newborns born to mothers RT-PCR positive for Z. ebolavirus infection): IV: 50 mg/kg each of atoltivimab, maftivimab, and odesivimab as a single dose.
Zaire ebolavirus infection: Infants, Children, and Adolescents: IV: 50 mg/kg each of atoltivimab, maftivimab, and odesivimab as a single dose.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
(For additional information see "Atoltivimab, maftivimab, and odesivimab (United States: Available via manufacturer expanded access or public health distribution): Drug information")
Zaire ebolavirus infection: IV: 50 mg/kg each of atoltivimab, maftivimab, and odesivimab as a single dose (Ref).
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Cardiovascular: Hypotension (15%), tachycardia (20%)
Endocrine & metabolic: Increased serum potassium (13%)
Gastrointestinal: Diarrhea (11%), vomiting (19%)
Hepatic: Increased serum aspartate aminotransferase (21%)
Nervous system: Chills (39%)
Renal: Increased serum creatinine (15%)
Respiratory: Tachypnea (19%)
Miscellaneous: Fever (54%)
1% to 10%:
Endocrine & metabolic: Decreased serum potassium (9%), decreased serum sodium (7%), increased serum sodium (9%)
Hepatic: Increased serum alanine aminotransferase (10%)
Respiratory: Hypoxia (10%)
Postmarketing:
Hypersensitivity: Hypersensitivity reaction
Miscellaneous: Infusion related reaction
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Hypersensitivity reactions: Hypersensitivity reactions, including life-threatening infusion-related reactions, have been reported during and after receipt of atoltivimab, maftivimab, and odesivimab. Monitor for signs and symptoms such as fever, chills, and hypotension. May slow or interrupt infusion for any signs of infusion-related reaction or other adverse effects; immediately discontinue for severe or life-threatening hypersensitivity reaction.
Other warnings/precautions:
• Immunizations: Avoid concurrent administration of a live vaccine during treatment with atoltivimab, maftivimab, and odesivimab.
Inmazeb: FDA approved October 2020. Product will not be commercially available; will only be distributed for a public health emergency in the US.
Regeneron will provide atoltivimab, maftivimab, and odesivimab in response to outbreaks in the Democratic Republic of the Congo through the Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI) protocol for compassionate use and is actively working with non-governmental agencies to ensure continued access to atoltivimab, maftivimab, and odesivimab in low- and middle-income countries. See inmazeb.com for more information.
IV: Must be diluted prior to administration. Allow diluted infusion to reach room temperature prior to administration; preparations diluted with D5W may be infused at temperatures up to 35°C (95°F), if temperature is >25°C (77°F) administer immediately after preparation. Administer through an IV line containing a 0.2-micron filter. Infusion time is based on patient weight. Slow or interrupt infusion if the patient develops any signs of infusion-associated events (eg, hypotension, chills, fever elevation) or other adverse events; if severe or life-threatening hypersensitivity reactions occur, immediately discontinue infusion and provide emergency care.
Infusion duration based on patient weight:
0.5 to <2 kg: Infuse over 4 hours.
2 to <16 kg: Infuse over 3 hours.
16 to <150 kg: Infuse over 2 hours.
≥150 kg: Infuse over 4 hours.
IV: Allow diluted infusion solution to come to room temperature prior to administration; preparations diluted with D5W may be infused at temperatures up to 35°C (95°F); if temperature is >25°C (>77°F) administer immediately after preparation. Administer IV with 0.2-micron filter. Infusion rate is based on total volume: for 250 mL to 1 L, infuse over 2 hours; for 2 L, infuse over 4 hours. May slow or interrupt infusion for signs of infusion-associated events or other adverse events.
Prior to dilution: Store intact vials at 2°C to 8°C (36°F to 46°F). Protect from light; do not freeze or shake.
After dilution:
Diluted with NS: Store at room temperature up to 25°C (77°F) for no more than 8 hours or at 2°C to 8°C (36°F to 46°F) for no more than 24 hours. Do not freeze.
Diluted with D5W: Store at room temperature up to 25°C (77°F) for no more than 4 hours or at 2°C to 8°C (36°F to 46°F) for no more than 24 hours. Do not freeze.
Diluted with LR: Store at room temperature up to 25°C (77°F) or at 2°C to 8°C (36°F to 46°F) for no more than 4 hours. Do not freeze.
Treatment of infection caused by Zaire ebolavirus (FDA approved in all ages).
Limitations of use: Efficacy not established for other species of the Ebolavirus and Marburgvirus genera.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Ebola Zaire Vaccine (Live): Ebola-Directed Monoclonal Antibodies may diminish the therapeutic effect of Ebola Zaire Vaccine (Live). Management: Wait several months (3 to 6 months, and up to 11 months) after use of Ebola-directed antibodies before administering the live Ebola Zaire vaccine. Repeat vaccination may be required if antibody therapy and vaccination cannot be adequately separated. Risk D: Consider therapy modification
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Atoltivimab, maftivimab, and odesivimab are humanized IgG1κ monoclonal antibodies and would be expected to cross the placenta. Placental transfer of human IgG is dependent upon the IgG subclass, maternal serum concentrations, newborn birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009).
A limited number of pregnant patients were included in a study that included treatment with atoltivimab, maftivimab, and odesivimab (Mulangu 2019).
Following maternal infection, the Ebola virus can be detected in maternal body fluids and transmitted to the fetus. Maternal Ebola infection carries a high rate of mortality for both the fetus and the mother. Maternal Ebola virus infection typically results in miscarriage, stillbirth, and maternal and/or neonatal death (Olgun 2018). Treatment with atoltivimab/maftivimab/odesivimab should not be withheld due to pregnancy.
Pregnant health care providers should not care for patients with Ebola virus disease (CDC 2018).
Monitor for hypersensitivity or infusion-related reactions (eg, hypotension, chills, elevation of fever) during and following infusion.
Atoltivimab, maftivimab, and odesivimab is an antiviral drug combination of 3 recombinant human IgG1κ monoclonal antibodies, each targeting the Zaire ebolavirus glycoprotein, which mediates viral attachment and host membrane fusion. Atoltivimab, maftivimab, and odesivimab can bind to the glycoprotein simultaneously. Maftivimab is a neutralizing antibody that blocks viral entry into host cells. Odesivimab is a non-neutralizing antibody that induces antibody-dependent effector function through FcyRIIIa signaling when bound to target; odesivimab also binds to soluble Zaire ebolavirus glycoprotein. Atoltivimab combines both neutralization and FcyRIIIa signaling activities.
Distribution: Mean Vd, steady state: Atoltivimab: 58.2 mL/kg; Maftivimab: 57.6 mL/kg; Odesivimab: 56 mL/kg.
Half-life elimination: Atoltivimab: 21.2 days; Maftivimab: 22.3 days; Odesivimab: 25.3 days.
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